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FDA Expedited Approvals of Expanded Cord Blood Products
As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
Parent's Guide to Cord Blood Foundation published a review of expanded cord blood products in May 2018.
Date |
Expanded |
Manufacturer |
Indication |
FDA Expedited Path(s) |
20180717 |
Gamida Cell |
HSCT: Hematopoietic |
Breakthrough Therapy |
|
20180806 |
NLA101 |
Nohla Therapeutics |
HSCT engraftment, |
Orphan Drug |
20180823 |
Medipost |
Bronchopulmonary Dysplasia |
Orphan Drug |
|
20190423 |
ExCellThera |
Hematologic |
Regenerative Medicine Advanced Therapy (RMAT) |
|
20190904 |
Magenta |
Inherited Metabolic Disorders |
Regenerative Medicine Advanced Therapy (RMAT) |